Tele-epic (Telemedicine for Epilepsy Care)

Azienda Usl di Bologna

Status: Unknown

Conditions: Epilepsy; Epileptic Encephalopathy; Refractory Epilepsy

Treatments: Procedure: Telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04496310

GR-2018-12365475

Details and patient eligibility

About

Epilepsy is a chronic condition that requires consistent follow-up aimed at seizure control, surveillance of comorbidities, monitoring of antiepileptic drugs (AED) levels and side effects. Patients may encounter difficulties to be assessed adequately and the disease burden is increased by the need for travelling across the country for medical consultations. Driving restrictions are a further limit to access specialized Centers able to provide an integrated approach focused on patient needs. Telemedicine (TM) offers an invaluable support to patient follow-up, joining the sparse distribution of patients in the country with the prompt availability of a team of experts. The project assesses, through a randomized controlled trial, the non-inferiority of TM in monitoring seizure control compared to usual (face-to-face) care. This approach, coupled with a new self home-sampling method for the measurement of AED levels, will reduce health care costs and simplify patients management.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• adult (age>18 yrs) and pediatric (age<18yrs) outpatients with established diagnosis of epilepsy.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Telemedicine

Experimental group

Description:

Baseline: in office clinical assessment of all patients (collection of seizure diary). Followup: scheduled 6-month consultations through a telemedicine device providing remote outcome assessment, counselling and follow-up. If required, on call video consultations available by contacting a provider through telemedicine, 3-hr/week.

Treatment:

Procedure: Telemedicine

Usual care

No Intervention group

Description:

Baseline: in office clinical assessment of all patients (collection of seizure diary). Followup: scheduled 6-month in-office consultations with outcome assessment, counselling and follow-up. On-call consultations are possible if needed by the patient, by contacting a clinician through an in-office phone call, 3-hr/week.